Cormedix Inc. · NASDAQ:CRMD
Cormedix — Investor Presentation (September 2018)
23 slides from Cormedix's investor presentation, September 2018
Slide 1: Harnessing Taurolidine Technology
HarnessingTaurolidine Technology Leading Development of Novel Anti-Infective Products in the Era of Increasing Bacterial Resistance September 2018 CORMEDIX 1
Slide 2: Forward-Looking Statements
FORWARD-LOOKING STATEMENTS This presentation contains certain statements that constitute forward-looking statements within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations, are forward-looking statements. Th
Slide 3: Financial Summary
FINANCIAL SUMMARY Founded January 2006 Exchange: Ticker NYSE American: CRMD Headquarters Berkeley Heights, NJ Employees 19 Common Stock O/S 97.8 Million Pref/CS Equivalents 18.3 Million Warrants Outstanding 22.9 Million Cash at June 30, 2018 $4.8 Million Debt $0 Recent Share Price $0.57 Recent Marke
Slide 4: Mission Statement
MISSION STATEMENT To harness our taurolidine technology for the prevention and treatment of infectious, inflammatory, and other serious diseases First commercial product candidate: Neutrolin® A novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infectio
Slide 5: Corporate Highlights
CORPORATE HIGHLIGHTS NEUTROLIN SIGNIFICANT MARKET OPPORTUNITY Non-antibiotic antimicrobial solution designed to prevent costly More than 400m vials of catheter lock solutions consumed in the U.S. and dangerous bloodstream infections associated with the use for all indications every year. of central
Slide 6: Management Team
MANAGEMENT TEAM Khoso Baluch CEO Robert Cook CFO Paul Chew Chief Medical Officer Jack Armstrong EVP Technical Operations Elizabeth Masson EVP & Head Of Clinical Operations Antony Pfaffle Chief Scientific Officer John Ortiz VP Regulatory Affairs & Quality Assurance CORMEDIX 6
Slide 7: Current Taurolidine Based Pipeline
CURRENT TAUROLIDINE BASED PIPELINE DRUG PIPELINE Product Category Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Hemodialysis Stopped for Efficacy at Interim Review July 2018 Neutrolin® U.S. Oncology ICU / CCU CMDX-001 Pediatric Neuroblastoma* * Orphan Disease Opportunity MEDICAL DEVICE PIP
Slide 8: Summary and Near-Term Milestones
SUMMARY AND NEAR-TERM MILESTONES Q1 2018 Q2 2018 Q3 2018 Q4 2018 Phase 3 Trial Stopped at Interim Review for Efficacy Neutrolin® U.S. FDA meeting planned Q4 2018 to agree on next steps to complete development plan Taurolidine Completed in vivo proof-of-concept data for various Platform Medical medic
Slide 9: Hemodialysis Is Life-Saving
HEMODIALYSIS IS LIFE-SAVING CRBSI is Life-Threatening CORMEDIX 9
Slide 10: Key Benefits of Neutrolin
KEY BENEFITS OF NEUTROLIN® NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI Prevents and reduces bloodstream infection. Bacteria and fungi, Antibiotic- NEUTROLIN® resistant strains, No reported resistance in Proprietary Formulation a clinical setting Taurolidine – 1.35% (anti-infective, ant
Slide 11: Medical Opportunity
MEDICAL OPPORTUNITY Despite improvements and initiatives to control infection, biofilm develops very quickly and can lead to life- threatening complications, costing the U.S. healthcare system billions of dollars annually SIGNIFICANT UNMET NEED 250,000 catheter-related bloodstream infections 01 (CRB
Slide 12: Neutrolin: Non-antibiotic Anti-infective To Prevent CRBSI
NEUTROLIN® Non-antibiotic Anti-infective To Prevent CRBSI NO MICROBIAL RESISTANCE SHOWN BROAD SPECTRUM OF COVERAGE Adaptation of microorganisms to taurolidine has Gram Positive Microorganisms not yet emerged as a factor in the pathogenesis Coagulase-negative Staphylococcus species and of CRBSI Staph
Slide 13: A New Superbug
A NEW SUPERBUG Hard to Detect But Easy to Cause Bloodstream Infections Source: CDC,https://www.cdc.gov/fungal/candida-auris/c-auris-drug-resistant.html CORMEDIX 13
Slide 14: CDC Risk Factor Analysis for C. auris
CDC RISK FACTOR ANALYSIS FOR C. AURIS Bloodstream, wound and ear infections CDC RISK FACTOR Broad-spectrum Recent surgery Diabetes ANALYSIS: antibiotic use Endotracheal tubes, Antifungal Recent Nursing Home feeding tubes, Central No Age Preferences use stay Catheters Infections by C. auris CORMEDIX
Slide 15: Reported Cases of C. auris in the US by Sept 2017
REPORTED CASES OF C. AURIS IN THE US BY SEPT 2017 Source: CDC,https://www.cdc.gov/fungal/candida-auris/c-auris-drug-resistant.html CORMEDIX 15
Slide 16: CDC Guidelines Upgraded in 2011 to Recommend Antimicrobial Locks
CDC GUIDELINES UPGRADED IN 2011 TO RECOMMNED USE OF ANTIMICROBIAL LOCKS Although antimicrobial locks are associated with a significant reduction in CRBSI, they are not CDC Recommendation recommended for routine use because of: Use prophylactic antimicrobial lock • Potential for side effects solution
Slide 17: Neutrolin Clinically Validated in Real World Study
NEUTROLIN CLINICALLY VALIDATED IN REAL WORLD STUDY Neutrolin Usage Monitoring Program (NUMP) Neutrolin Significantly Reduces Open-label, post-market observational study Infection and Thrombosis RATE PER 1000 CATHETER DAYS PRIMARY GOAL Benchmark Data Neutrolin Monitor safety and efficacy of CE Marked
Slide 18: FDA Recognizes Potential of Neutrolin
FDA RECOGNIZES POTENTIAL OF NEUTROLIN APPROVAL PATHWAY Designated an investigational new drug by FDA (Catheter LOCK Solution Investigational Trial) 10.5 YEARS Granted FDA Fast Track 5 years exclusivity Potential Market Exclusivity Granted Qualified Infectious Disease Product (QIDP) 5 years exclusivi
Slide 19: LOCK-IT-100 Preventing CRBSI in Dialysis Patients
LOCK-IT 100 PREVENTING CRBSI IN DIALYSIS PATIENTS DESIGN OBJECTIVE PRIMARY ENDPOINT SECONDARY ENDPOINTS Phase 3, multicenter, double- Demonstrate the efficacy and Time to occurrence of CRBSI Catheter patency: loss of blind, randomized (1:1), active safety of Neutrolin® as a catheter patency followin
Slide 20: LOCK-IT-100 Current Status
LOCK-IT 100 CURRENT STATUS Successful Interim Analysis for Convincing Efficacy in July 2018 DSMB Recommended Study Stop: CRMD Remains Blinded Study Closeout Proceeding Preparing Request to Meet FDA in 4Q2018 Pending FDA Discussion CORMEDIX 20
Slide 21: Catheter Lock Solutions: U.S. Market Potential
CATHETER LOCK SOLUTIONS U.S. Market Potential is Significant Estimated Catheter Vials per Total Neutrolin® Patients Days Catheter Day Units Hemodialysis 660,000 63mm 0.5 31mm Catheter Population and Opportunity Oncology/TPN 7,740,000 90mm 3 270mm ARE SIGNIFICANT ICU 5,700,000 29mm 5 143mm 444mm Comp
Slide 22: Summary and Near-Term Milestones
SUMMARY AND NEAR-TERM MILESTONES Q1 2018 Q2 2018 Q3 2018 Q4 2018 Phase 3 Trial Stopped at Interim Review for Efficacy Neutrolin® U.S. FDA meeting planned Q4 2018 to agree on next steps to complete development plan Taurolidine Completed in vivo proof-of-concept data for various Platform Medical medic
Slide 23: Thank You
NYSE American CRMD @CorMedixInc @Investor & Media Contacts THANK LifeSci Advisors, LLC Dan Ferry daniel@lifesciadvisors.com YOU 617-535-7746 400 Connell Drive Suite 5000 Berkeley Heights, NJ 908.517.9500 CORMEDIX